Human Error Reduction
“The Beginning of Diagnostics’ New
Tomorrow”
Nigel Paterson
Manufacturing Team Leader
Agenda
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Company Overview
Quality Improvement Program Overview
The Science of Human Error
Proven Learning Methodology
Owner and Community Model
Measurements of Success
Current Status
Q&A
Abbott Diagnostics Global Network
Lake County
Sligo
Longford
Dartford, UK
Dallas
Wiesbaden, Germany
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Longford Operations
• 135,000 ft2 facility on 20 acre site
• Approx. 365 employees
• 2 shift/5 day operation
30 individuals on evening shift
Day Shift: 8.00am- 4.30pm
Evening Shift: 4.00pm – 12.00am
ADD Longford Product Portfolio
THYROID FUNCTION
CARDIOVASCULAR INDICATORS
ARCHITECT TSH
ARCHITECT FT4
ARCHITECT TT4
ARCHITECT FT3
ARCHITECT TT3
AxSYM FREE T4
AxSYM FREE T3
AxSYM UltraSensitive
AxSYM 3rd Gen TSH
AxSYM Troponin-I (Adv)
AxSYM CK-MB
AxSYM Myoglobin
METABOLIC ACTIVITY
ARCHITECT Ferritin
ARCHITECT Folate
ARCHITECT B12
AxSYM Ferritin
AxSYM Folate
AxSYM B12
AxSYM Troponin
RENAL FUNCTION
FERTILITY & PREGNANCY
ARCHITECT Total BhCG
ARCHITECT FSH
ARCHITECT Prolactin
ARCHITECT Estradiol
ARCHITECT Progesterone
ARCHITECT LH
ARCHITECT Testosterone
AxSYM BHCG
DRUG MONITORING
AxSYM Cyclosporine
ARCHITECT NGAL
A New Global Initiative Program
• This Program is a global initiative across our business to simplify
and harmonize our quality system and manufacturing processes
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Initiated in June 2008
All components of the quality system – design to manufacture to logistics
Led and supported by global resources
Focused on revolutionary continuous improvement as a core driver
Applied human factor engagement to
• Simplify processes and procedures
• Introduce competency based learning
• Reduce infrastructure to yield less errors and production issues
• Sustainability is achieved through the implementation of global
Process Communities for the Quality System and Manufacturing
process throughout the division
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Toolset
PPMs
Process
Picture Maps
H.E.R
Decision
Errors advanced
GOL
HEID
Goal
Oriented
Learning
(Human Error
Investigation &
Diagnostic)
H.E.R
Doc Design
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Forms
Mentoring
& Coaching
H.E.R
(science of
human
errors)
HERO
H.E.R
Safety
HERA
(Human Error
Retrospective
Analysis)
(Human Error
Reduction
Opportunity)
Writing
Effective
Procedures
All are trade-marked methodologies of Talsico, Inc.
What are Human Errors?
“An inappropriate action or
response by a person
resulting in an undesired
outcome”
Human Error Categories
Category
• (1) Learning Gap
Issue
don’t know
Cause
lack of skills or knowledge, or
insufficient understanding of
consequences
• (2) Memory Gap
know but don’t remember
unable to use skill or knowledge at
time required
• (3) Inconsistency
know but variability in method
• (4) Application
know but applied incorrect action slips, wrong outcomes, transcription
inconsistent performance/ results
• (5) Omission
know but missed a step
missing info, used wrong item
• (6) Decision
wrong decision given situation
inappropriate decision
errors
Copyright of Talsico, Inc.
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The Science of the Brain
Recall vs Recognition
‘Autopilot’
Alerting the Brain
Recall….Ford Cars
Write down the names of the 9 current
models of Ford cars
Tough to do, right?
Copyright of Talsico, Inc.
Recognition….Ford Models
From the list below, write down the names of
the 9 Models of Ford Cars
a) Vectra
f) Xantia
k) Fluence
b) Ka
g) Mondeo
l) C-Max
d) Legacy
i) Kuga
n) Focus
e) Fusion
j) Fiesta
o) Galant
c)
What do h)
you
think now?
S-Max
Galaxy
m) Corsa
Copyright of Talsico, Inc.
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Recognition vs Recall
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Recognition easier to learn,
less error-prone, more
stable than recall.
Where possible, design for
recognition rather than recall
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Brain uses 2 different processes for
remembering!
Recognition - “from a list, point out ..”
Has external starting point
Recall – no external starting point
Recognition vs Recall – learn to req’d level
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Recognition – use
SOPs, aids, system
prompts, PPMs. Must
be accessible otherwise
forces “recall”
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Accessible?
Physical Accessibility =
“Within Reach”
Cognitive Accessibility =
Easy to “Grab” req’d info
Copyright of Talsico, Inc.
Running on Autopilot
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A growing body of research suggests that as little as 5 percent of our
behaviors are made consciously. This means that as much as 95 percent
of what we do occurs in autopilot mode
Most skills and behaviors you learn eventually become automatic habits
Stored in the ‘hidden’ part of the brain
Accessed only as sequence in order stored! Attention at start & decision
points
• Example: Riding a bike
Morning Routine
Driving to and from Work
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What happens if you need to break that process or learn new skills? –
Prone to Error
Learning Method must provide a way of changing that process
Autopilot: Adding a step…
New Step
Existing Process
New Process
What’s the Brain Trying to Do?
‘Conscious’ Part
‘Hidden’ Part
Existing Process Must be ‘Interrupted’ and new step
must move to hidden part of brain to form habit
Copyright of Talsico, Inc.
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Alerting the brain
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The Brain needs a ‘trigger’ to initiate a response or highlight changes
Some ‘triggers’ are inbuilt
• Hunger
• Thirst
• Fatigue
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We experience external ‘triggers’ daily
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Headlight Alarm
Phone Message Alert
Warnings on delivery boxes – ‘fragile’, ‘this way up’
Colours on Fuel Pumps
Arrows on roads
These must be appropriate – in placement, size and manner
Appropriate Alerts need no interpretation and provoke the correct
reaction
How can these be built into documents?
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Copyright of Talsico, Inc.
Building Alerts into Documents
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In order of effectiveness
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Sound – Seat Belt Alarm, Headlights, Fire Alarm
Motion or Pattern – Flashing Lights/signs
Colour
Shape
Text
In documentation
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Layout acts as a trigger – field, table structure, following a
pattern, natural order
Colours – perform and verify
Highlights
Shapes – Consistency across documents
Copyright of Talsico, Inc.
Initial State: ADD’s Document Structure
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Multiple layers of redundant information on a foundation of training
through read and understand.
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Vision: Document Structure
• Three levels of documentation on a
foundation of learning.
How the New Quality Program Is Being Implemented:
Philosophies and Processes
FROM…
TO…
BENEFIT
Local thinking
Global thinking
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Many layers of
redundant
documents created
at each site
Universal
documents managed
by process
communities
• Consistency in processes between sites
• Communities can work together for continuous
improvement
Long, confusing or
overwhelming
Manufacturing
Formulas, Operating
Procedures, STPs
Process Picture
Maps™
• Easy to read and understand processes;
• Attention activators reduce errors;
• Elimination of non-value added steps
(Small Documents)
• created with employee input for maximum buy-in
Read-and-forget
training and
inconsistent on the
job training
Goal-Oriented
Learning™
Learning Units
• Consistent, sustainable training based on best
practices in human learning Improvement in
employee satisfaction, performance
• Shared, consistent, enduring knowledge among all
ADD employees through standardized procedures
(Big Knowledge)
Inter-site transparency
Harmonized approach to compliance
Common documents
Best-of-the-best benchmarking
Training System – Original State
• The original training system was limited by
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Excessive & redundant volume of documents
“Read & understand” paradigm
Lack of global learning plans
Lack of global certification programs
Limited technical training
Limited just in time training
Restricted use of technology
Errors and waste
Untapped human capability
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Learning System - Desired Future State
• A global learning system that certifies employees to do their
jobs efficiently and effectively, on an as-needed basis,
without taking them off the job
• A Goal Oriented Learning™ system supports business
performance:
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Increases global business flexibility
Provides certification of employee competence
Recognizes employees’ prior work experience
Incorporates rigorous assessment and verification of demonstrated
competence
• Integrates and unifies best practices from Safety, Quality, and
Compliance
• Puts responsibility and accountability for learning and certification in
hands of employee
Efficient : Competency-Based
1. Learning Unit
LU • Knowledge-Generating Activities
– Unit Overview
– Activity Verification
Form
– Resource Guide
– Assessment Plan
4. Certification
• Successful Assessment
• Record of Achievement
• Entered into Database
2. Verification
• Verify Learning Activities
• Reinforcing Feedback
• Corrective Feedback
3. Assessment
• Structured Procedure
• Assessor & Observer
• Principles of
– Validity
–Flexibility
– Reliability –Fairness
A trade-marked methodology of Talsico, Inc.
Process Owner/Community
• Process Owner/Community structure is the long-term sustainability model
to maintain the simplified processes and culture of ownership and
decision making at the ground level.
• Process Owner/Communities are the divisions experts for the given
process.
• Process Owner located at one of the sites and each participating site has
a process community member
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Process Owner
• Oversight:
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Propose KPI’s (with input from process community) to monitor process.
Ensure that the process remains current, complete, and compliant with Abbott
Policy documents, External Standards/Regulations and industry best practices.
Assemble Key Process Scorecard
Global Document Owner (PPM’s & Learning Units)
• Facilitates and coordinates Process Community input for Learning Unit & Global
document development/changes.
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Learning Deployment
• Ensure consistent global learning occurs for the process (i.e. cross
verification).
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Establish Process Community Meetings to:
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Participate in the deployment of learning by facilitating an agreed set of responses (answers)
from the Process Community & SME’s into the Learning Unit to ensure consistent global
learning occurs for their process.
Review Metrics
Evaluate potential document updates
I.D. possible process improvements
Benchmark between sites
Process Owner (cont)
• Continuous Improvement:
• Identify potential Quality Plan / Improvement projects:
• Quality Plan: Align qualification / validation packages
for a given process across sites, assess existing
procedures related to a given process for further
simplification and/or document reduction
• Process Improvement: Up scale/down scale process,
efficiency, robustness (reduce variation of a certain
product performance parameter across batches,
compare output variability of products across sites
• Lead Process Community during process improvement
projects
• Responsible for global investigations and associated
corrective/preventive actions
• Hook into Global CAPA Steering Committee (GCSC)
Process Community
• Quality and Manufacturing Process Communities are comprised of
individuals from across the division that are knowledgeable on the
process and are responsible for the measurement and continuous
improvement of their process.
• Oversight:
• Identify performance indicators for Key Process Scorecard
• Gather performance indicator data for their respective site.
• Key contact for process specific issues at their respective sites.
• Learning Deployment
• Ensure consistent global learning occurs for the process (i.e. cross verification).
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Participate in the deployment of learning by facilitating an agreed set of responses (answers) from the
Process Community & SME’s into the Learning Unit to ensure consistent global learning occurs for their
process.
• Continuous Improvement:
• Assess documents for process improvement opportunities
• Collaborate on process improvement projects
• Participate in global investigations and associated corrective/preventive actions
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Pilot Workstream
• Pilot area for Quality Improvement Program
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Small Manufacturing area with relatively few technicians
Technical process
Large opportunity for Human Error
Large Cost Impact of Error
Month (2008)
Activity
May / June
Training (Incl HERA & HERO Activities)
July
Style Guide & Building Blocks Finalised in Line
with Inter-Site Harmonisation
August
Documents Authored & Approved
Go Live Readiness
Pilot Activities
September
October/ November
Complete Pilot
Document Lessons Learnt
Implement Lessons Learnt
Feedback & Align with Other Sites
Before = OP for Operation and Assembly
After = 2 Process Picture Maps
4 pages
88% Reduction In Text
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Before = Longford Training System
4 OJT’s
26 Associated
Documents
~231 pages of
material
7 Presentations
1 Presentation
1 Presentation
1 Presentation
5 Assesments
1 Assesment
1 Assesment
1 Assesment
1 OJT course cover
sheet
1 OJT course cover
sheet
1 OJT course cover
sheet
1 OJT course cover
sheet
1 Training record
1 Training record
1 Training record
1 Training record
1 LU
After = Learning Unit
1 Document
31 Pages
Metrics - Benefits
Exception Report (ER) Rate:
Exception Reports raised in the operations area due to Human Error
issues pre- and post-implementation were quantified
Pre-Implementation (03 Apr 07 to 03 Mar 08):
23 ERs per 100 Shop Orders
Post-Implementation (01 Sep 08 to 31 Jan 09):
8 ERs per 100 Shop Orders
2011 – 101 Shop Orders – 2 ERs
2012 - 0 ERs
Financial
Efficiency
•MQA Touch Time:
28% reduction
• MDO Reduction:
63%
• ER Reduction/100
SO: 87%
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Measurements of Success – Document Change
Revolution
Before
After
% Reduction
Pages
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25
42
Text
36462
9335
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Transcriptions
93
32
66
Entries
908
357
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Sign & Date
130
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The Voice of the Customer
Manufacturing Team
“The new 'Go verify' system
of training is very
impressive: better training
will be given & received in
the future”
Quality Reviewer
“The document layout is
much better. I particularly
like the new calculation
format and use of colour!”
“The use of pictures in
PPMs is excellent!”
“New documents will be
much shorter to review. The
use of colour makes the
documents easier to follow”
Early Wins…. Corrective and Preventative
Actions (CAPA) Pilot
Four Large Operating
Procedures of 57 Pages…
CAPA
CAPA
OP #1
CAPA
OP #2
CAPA
OP #1
OP #2
CAPA
…Reduced to a 2-page Process
Picture Map & 1 Learning Unit
CAPA
OP #3
OP #4
CAPA
CAPA
OP #3
OP #4
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Quality Program Implementation Successes
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Harmonised processes across sites
Greater communication between sites
Human Error reduction
Ease of Use of Documents
MQA (Batch Record) review time
Simplification of documents
Audit Management – easier to explain processes
No adverse consequences
Systematic, consistent and faster learning
• NOTE: This requires a Resource and Time
Commitment for Implementations and for GOL
Learning
Quality Program Current Status
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Implementations Complete
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Change Control/Planning
Management Responsibility
CAPA
Nonconformance
Design Control
Supplier Control
Validation
Risk Evaluation
LIR (Lab Investigation)
Complaints
Learning
Labelling
Material Criticality
Spec Setting
Risk Management
PO/PC
Process Monitoring
AMPS
Conjugation
Kitpack
Solutions
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Implementations In Process
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Non Inventory Material Control
Warehousing/Receiving
Fill/Label
Magnetic Separation
Product Monitoring
Microbial Testing
Full Program planned for 2013
Thank You
Questions??
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